NCT03602677

Brief Summary

This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,062

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

March 25, 2018

Last Update Submit

March 24, 2023

Conditions

Colorectal CancerColorectal NeoplasmsGastrointestinal CancerGastrointestinal NeoplasmsDiverticulosis, ColonicGastrointestinal Disease

Keywords

Colorectal surgeryAnastomosisAnastomosis leakFluorescence imaging

Outcome Measures

Primary Outcomes (1)

  • Anastomosis leakage rate

    0 to 90 days

Secondary Outcomes (12)

  • Severity of anastomosis leakage

    0 to 90 days

  • Timing of anastomosis leakage

    0 to 90 days

  • Deep surgical site infections

    0 to 90 days

  • Hospital readmission rate

    0 to 90 days

  • Reoperation rate

    0 to 90 days

  • +7 more secondary outcomes

Study Arms (2)

ICG fluorescence imaging

EXPERIMENTAL

Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.

Device: ICG fluorescence imaging

Standard procedure

NO INTERVENTION

Standard colorectal surgery and anastomosis.

Interventions

ICG fluorescence imagingDEVICE

The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.

ICG fluorescence imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
  • Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold).

You may not qualify if:

  • Emergent patients
  • Patients with proven diverticular abscess and colonic fistulas are excluded
  • Patients with planned open surgery are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Finland Central Hospital

Jyväskylä, Finland

RECRUITING

Päijät Häme Central Hospital

Lahti, Finland

RECRUITING

Related Publications (1)

  • Rinne JKA, Huhta H, Pinta T, Turunen A, Mattila A, Tahkola K, Helminen O, Ohtonen P, Rautio T, Kossi J. Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):486-493. doi: 10.1001/jamasurg.2025.0006.

    PMID: 40042831DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsGastrointestinal NeoplasmsDiverticulosis, ColonicGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jyrki Kössi, MD, PhD

    Päijänne Tavastia Central Hospital

    PRINCIPAL INVESTIGATOR

  • Olli Helminen, MD, PhD

    Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland

    PRINCIPAL INVESTIGATOR

  • Heikki Huhta, MD, PhD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

  • Juha Rinne, MD

    Päijänne Tavastia Central Hospital

    PRINCIPAL INVESTIGATOR

  • Matti Kairaluoma, MD, PhD

    Central Finland Central Hospital, Jyväskylä, Finland

    PRINCIPAL INVESTIGATOR

  • Tero Rautio, MD, PhD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyrki Kössi, MD, PhD

CONTACT

+358381911jyrki.kossi@phhyky.fi

Olli Helminen, MD, PhD

CONTACT

+358142691811olli.helminen@oulu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Resident, Surgery

Study Record Dates

First Submitted

March 25, 2018

First Posted

July 27, 2018

Study Start

September 24, 2018

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)